Good Clinical Practice (GCP)
GPTKB entity
Statements (47)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:abbreviation |
gptkb:GCP
|
| gptkbp:adoptedBy |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
gptkb:European_Medicines_Agency_(EMA) gptkb:Pharmaceuticals_and_Medical_Devices_Agency_(PMDA) |
| gptkbp:appliesTo |
clinical trials involving human subjects
biological product clinical trials medical device clinical trials multinational clinical trials pharmaceutical clinical trials |
| gptkbp:basisFor |
clinical trial approval
regulatory inspections |
| gptkbp:category |
medical guideline
clinical trial regulation |
| gptkbp:developedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use_(ICH)
|
| gptkbp:enforcedBy |
regulatory authorities
|
| gptkbp:field |
clinical research
|
| gptkbp:firstPublished |
1996
|
| gptkbp:focusesOn |
credibility of clinical trial data
rights, safety, and well-being of trial subjects |
| https://www.w3.org/2000/01/rdf-schema#label |
Good Clinical Practice (GCP)
|
| gptkbp:ICHGuidelineNumber |
E6
|
| gptkbp:includes |
informed consent
auditing data integrity monitoring protocol adherence investigator responsibilities sponsor responsibilities |
| gptkbp:language |
English
|
| gptkbp:purpose |
ensure ethical and scientific quality of clinical trials
|
| gptkbp:referencedIn |
gptkb:EMA_guidelines
gptkb:FDA_21_CFR_Part_312 gptkb:WHO_guidelines |
| gptkbp:relatedTo |
gptkb:Belmont_Report
gptkb:Declaration_of_Helsinki |
| gptkbp:requires |
manual
quality assurance adverse event reporting risk management confidentiality ethics committee approval qualified investigators |
| gptkbp:trainingRequiredFor |
clinical research professionals
|
| gptkbp:updated |
periodically
|
| gptkbp:bfsParent |
gptkb:FDA_Guidelines
|
| gptkbp:bfsLayer |
6
|